Conflict of interest remains a thorny topic in the conduct, analysis and dissemination of clinical trials. Four panelists on a recent Windhover Webinar offer their perspectives on how private companies can best align with the public interest goals of medical research. . . . [MORE . . .]

The FDA faces a difficult, legislatively-mandated requirement in the anti-infective area. It is charged with updating antibioitic susceptibility charts in labeling for all approved anti-infectives. That is a huge task -- almost equivalent to re-reviewing the large cadre of existing antibiotic drugs. To try to achieve the task, the agency has proposed trusting an outside standards group for help. That sounds like a practical solution; but Capitol Hill has political problems. . . . [MORE . . .]

Several of the highest profile new drug applications pending or expected to be submitted as 2010 begins involve potential blockbuster market opportunities. They also lack Big Pharma partners. Is Big Pharma really that picky? Or are the applications out of step with the regulatory and commercial climate? Either way, intense investor interest will keep FDA in the spotlight. . . . [MORE . . .]

Government and industry leaders discuss follow-on biologics, reverse payments and health care refrom. . . . [MORE . . .]

The long road to enacting health reform appeared to be close to an end with final negotiations taking place in the White House. But the Senate race for Ted Kennedy's open seat in Massachusetts has put the bill, and pharma's hard-fought concessions, in the breach. . . . [MORE . . .]

The US prescription drug market remains anemic, but don't blame the federal government. The Medicare Prescription Drug Benefit that began in 2006 is the only reason there has been any growth in the retail sector. No wonder industry is so eager for health care reform. . . . [MORE . . .]

An HHS departmental appeals board decision finds Purdue executives at fault despite plea and convictions based solely on the Dotterweich and Park doctrines . . . [MORE . . .]

FDA's transparency initiative is starting to take shape. While many industry executives see the value in making more information available to the public, one idea makes them nervous: publicizing the letters FDA sends when it declines to approve a new drug or biologic. Top FDA officials already support making "complete response" letters public, and the Commissioner's office is open to the idea. How should industry prepare? . . . [MORE . . .]